Mobile Sleep Intervention for OEF, OIF and OND Veterans
Status: | Completed |
---|---|
Conditions: | Insomnia Sleep Studies |
Therapuetic Areas: | Psychiatry / Psychology |
Healthy: | No |
Age Range: | 21 - 65 |
Updated: | 4/22/2018 |
Start Date: | October 20, 2015 |
End Date: | November 16, 2016 |
Mobile Sleep and Pain Intervention for OEF, OIF and OND Veterans
Many Veterans of the recent wars in Iraq and Afghanistan struggle with chronic insomnia
(trouble falling or staying asleep). Most current interventions for insomnia are
time-consuming, making it difficult for this younger, working group of Veterans to use and
benefit from these interventions. The investigators will assess whether Veterans find it
helpful to use two health information technology tools, one for measuring participant sleep
(the WatchPAT) and one for managing participant sleep (the CBTI Coach). The WatchPAT will
measure physiological sleep in the Veteran participant's home. The CBTI Coach is a mobile
health application used on the Veteran's mobile phone or tablet to teach skills that can
reduce insomnia. The investigators will combine use of the WatchPAT with the CBTI Coach so
Veterans can self-manage insomnia at home. Participants will record their physiological sleep
and self-report on their sleep at home during a 6 week self-management program. The
investigators will measure if Veterans find the tools helpful and easy to use, and which
Veterans find the tools most helpful.
(trouble falling or staying asleep). Most current interventions for insomnia are
time-consuming, making it difficult for this younger, working group of Veterans to use and
benefit from these interventions. The investigators will assess whether Veterans find it
helpful to use two health information technology tools, one for measuring participant sleep
(the WatchPAT) and one for managing participant sleep (the CBTI Coach). The WatchPAT will
measure physiological sleep in the Veteran participant's home. The CBTI Coach is a mobile
health application used on the Veteran's mobile phone or tablet to teach skills that can
reduce insomnia. The investigators will combine use of the WatchPAT with the CBTI Coach so
Veterans can self-manage insomnia at home. Participants will record their physiological sleep
and self-report on their sleep at home during a 6 week self-management program. The
investigators will measure if Veterans find the tools helpful and easy to use, and which
Veterans find the tools most helpful.
Sleep disturbance in the form of chronic insomnia (difficulty in falling or staying asleep)
is a major health care problem for Operation Enduring Freedom (OEF), Operation Iraqi Freedom
(OIF), and Operation New Dawn (OND) Veterans. Chronic insomnia is often co-morbid with mental
and behavioral health issues such as posttraumatic stress disorder (PTSD) and mild traumatic
brain injury (mTBI), which are common in these Veterans. Current behavioral interventions
like cognitive behavioral therapy for insomnia (CBTI) that are used to treat chronic insomnia
are effective, but time-consuming. As a result, this largely younger, working cohort of
Veterans does not use and benefit from these interventions as much as they could. The
investigators will assess the usability and feasibility of two health information technology
(HIT) tools for measuring objective and subjective sleep, and for self-managing chronic
insomnia. An existing mobile sleep monitoring device used by some VA sleep clinics, the
WatchPAT, will be used to measure objective sleep parameters in the Veteran's home. A benefit
of this tool is that it can detect probable sleep apnea, which will permit referral of these
Veterans for sleep apnea treatment instead of insomnia self-management. An existing VA mobile
health application (or app), the CBTI Coach, can be used on a mobile device to teach skills
to reduce insomnia based on the elements of manualized CBTI. The goal is to combine the
WatchPAT and the CBTI Coach along with self-management guidance to help Veterans with chronic
insomnia learn how to improve their sleep. As part of a 6-week pre-post intervention pilot
usability and feasibility trial, patients will record their objective and subjective sleep at
home at the beginning of the 6-week self-management trial and again at the end. Subjective
sleep reports in the form of sleep diaries will be measured throughout the program as part of
using the CBTI Coach app. The objective and subjective sleep reports will be combined and
accessible from the mobile device and can be used to help guide sleep self-management by the
participant. Self-management will be aided by self-management worksheets and features of the
CBTI Coach App. Usability of the two HIT tools will be assessed within the conceptual
framework of an Integrated Technology Acceptance Model via survey items about each of the HIT
tools. Feasibility will be assessed using measures of the number of times that elements of
the CBTI Coach were accessed during the 6-week program, and from a semi-structured
qualitative interview conducted at the end of the program. In the interview, the
investigators will obtain information about the barriers to and facilitators of use of the
WatchPAT and CBTI Coach. If there is high use of these tools for insomnia self-management,
then the pilot study will have provided important incremental value to the new VA CBTI Coach
app. The investigators also will collect data about the user factors that impact use of the
tools (e.g., depression, mild traumatic brain injury, age), and thereby either be able to
target the tools toward those most likely to use them, or suggest further developments to
increase use by potential users. The pilot sample will provide preliminary data on sleep
outcomes. The proposed work is responsive to multiple priority areas for HSR&D including
Healthcare Informatics, Healthcare Access, Mental and Behavioral Health, and Post-deployment
Health. By partnering with the VA Office of Connected Health (Web and Mobile Solutions), the
VA's eHealth QUERI, and the developers of the VA CBTI Coach App, the investigators will
ensure that these findings are maximally useful for future versions of the CBTI Coach app.
The investigators also will be able to determine the usefulness of an integrated mobile sleep
assessment and self-management program that can be used by Veterans anywhere.
is a major health care problem for Operation Enduring Freedom (OEF), Operation Iraqi Freedom
(OIF), and Operation New Dawn (OND) Veterans. Chronic insomnia is often co-morbid with mental
and behavioral health issues such as posttraumatic stress disorder (PTSD) and mild traumatic
brain injury (mTBI), which are common in these Veterans. Current behavioral interventions
like cognitive behavioral therapy for insomnia (CBTI) that are used to treat chronic insomnia
are effective, but time-consuming. As a result, this largely younger, working cohort of
Veterans does not use and benefit from these interventions as much as they could. The
investigators will assess the usability and feasibility of two health information technology
(HIT) tools for measuring objective and subjective sleep, and for self-managing chronic
insomnia. An existing mobile sleep monitoring device used by some VA sleep clinics, the
WatchPAT, will be used to measure objective sleep parameters in the Veteran's home. A benefit
of this tool is that it can detect probable sleep apnea, which will permit referral of these
Veterans for sleep apnea treatment instead of insomnia self-management. An existing VA mobile
health application (or app), the CBTI Coach, can be used on a mobile device to teach skills
to reduce insomnia based on the elements of manualized CBTI. The goal is to combine the
WatchPAT and the CBTI Coach along with self-management guidance to help Veterans with chronic
insomnia learn how to improve their sleep. As part of a 6-week pre-post intervention pilot
usability and feasibility trial, patients will record their objective and subjective sleep at
home at the beginning of the 6-week self-management trial and again at the end. Subjective
sleep reports in the form of sleep diaries will be measured throughout the program as part of
using the CBTI Coach app. The objective and subjective sleep reports will be combined and
accessible from the mobile device and can be used to help guide sleep self-management by the
participant. Self-management will be aided by self-management worksheets and features of the
CBTI Coach App. Usability of the two HIT tools will be assessed within the conceptual
framework of an Integrated Technology Acceptance Model via survey items about each of the HIT
tools. Feasibility will be assessed using measures of the number of times that elements of
the CBTI Coach were accessed during the 6-week program, and from a semi-structured
qualitative interview conducted at the end of the program. In the interview, the
investigators will obtain information about the barriers to and facilitators of use of the
WatchPAT and CBTI Coach. If there is high use of these tools for insomnia self-management,
then the pilot study will have provided important incremental value to the new VA CBTI Coach
app. The investigators also will collect data about the user factors that impact use of the
tools (e.g., depression, mild traumatic brain injury, age), and thereby either be able to
target the tools toward those most likely to use them, or suggest further developments to
increase use by potential users. The pilot sample will provide preliminary data on sleep
outcomes. The proposed work is responsive to multiple priority areas for HSR&D including
Healthcare Informatics, Healthcare Access, Mental and Behavioral Health, and Post-deployment
Health. By partnering with the VA Office of Connected Health (Web and Mobile Solutions), the
VA's eHealth QUERI, and the developers of the VA CBTI Coach App, the investigators will
ensure that these findings are maximally useful for future versions of the CBTI Coach app.
The investigators also will be able to determine the usefulness of an integrated mobile sleep
assessment and self-management program that can be used by Veterans anywhere.
Inclusion Criteria:
- Participants must have served in the most recent wars in Iraq or Afghanistan (OIF, OEF
or OND),
- be age 21-65,
- report current insomnia as defined by an Insomnia Index Severity 40 score > 10 5,79,
- and report insomnia duration of at least 1 month and impaired daytime functioning (as
measured by endorsing Much or Very Much on ISI Item 7 about how much sleep problems
interfere with daily functioning).
- In addition, eligible individuals must be willing to use a device provided by the
study team (an iPod touch).
Exclusion Criteria:
- Exclusions will include self-reported (or in-study determined) sleep apnea that is
more than mild,
- periodic leg movements,
- or circadian rhythm disorder (delayed or advanced sleep phase).
- Exclusions for WatchPAT use include use of alpha blockers or short-acting nitrates,
- permanent pacemaker, or
- sustained non-sinus cardiac arrhythmias. Sleep apnea will be assessed from the
WatchPAT on the first night of objective sleep testing and participants excluded from
further participation if apnea is documented.
- Other exclusions include moderate to severe cognitive impairment defined by scores on
the Telephone Mini Mental State Exam,
- inability to speak and read English,
- or malformation of the fingers that would preclude use of the WatchPAT device.
- In addition, individuals meeting criteria for current active psychosis, mania,
suicidal ideation with plan and intent, or excessive alcohol use as determined using
the AUDIT-C will be excluded from participation.
- Those with greater than mild sleep apnea as determined based on a WatchPAT-based
Apnea-Hypopnea Index [AHI] > 15/hour of sleep, will be withdrawn from the study and
referred for sleep apnea treatment.
We found this trial at
1
site
Bedford, Massachusetts 01730
Principal Investigator: Karen S. Quigley, PhD
Phone: 781-687-2975
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